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510(k) Data Aggregation
K Number
K222357Device Name
DenMat Glutaraldehyde Desensitizer
Manufacturer
Date Cleared
2022-08-09
(5 days)
Regulation Number
872.3200Why did this record match?
Applicant Name (Manufacturer) :
DenMat Holding, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
· To reduce pain in exposed cervical areas not requiring restoration.
· To alleviate dentinal sensitivity after preparation of teeth to receive indirect or direct restorations.
Device Description
DenMat Glutaraldehyde Desensitizer is an aqueous, 5% glutaraldehyde-based desensitizer with 35% Hydroxy-ethyl Methacrylate (HEMA - a pre-primer resin) designed for use with 4th and 5th generation adhesives. DenMat Glutaraldehyde Desensitizer works by coagulating the plasma proteins contained within the dentinal tubule fluid. This coagulation forms an initial "plug" (which can be seen to a depth of 200 microns), eliminating the movement of fluid within the tubules-the root cause of dentinal sensitivity.
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